FDA Device recall Z-2759-2020
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted f…
- FDA Device
- Class II
- ongoing
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class II recall of Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted f… by Boston Scientific, citing BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2759-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-06 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.
Reason
BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
Identifiers
| code_info | Outer Package UPN #: M00561291 Inner Package UPN #: M00561290 GTIN: 08714729645801 Lot #s: 25170944, 25219286, 25368…Outer Package UPN #: M00561291 Inner Package UPN #: M00561290 GTIN: 08714729645801 Lot #s: 25170944, 25219286, 25368742, 25412118, 25508371 Expiration Dates: 5-Feb-23 through 13-May-23 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2759-2020%22
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